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NCT Number: NCT06674811

Biomarkers of Resiliency In Childhood Cancer Surgery

This observational study is to better understand how children and their families recover after the stress of major surgery for cancer so that investigators can create ways to improve resilience during recovery. The main questions it aims to answer are:

1. Can information obtained from patients and their caregivers wearing smartwatches and answering questionnaires be used to measure how patients are recovering from surgery? 2. Are there specific patterns in patients' circulating proteins and metabolites that are associated with stress after surgery?

Participants, including pediatric patients undergoing surgery for cancer and their primary caregiver, will be asked to:

* wear a smartwatch * complete questionnaires * allow for extra blood to be drawn for this research study when they are having their regular blood draws for clinical purposes

These actions will occur at baseline prior to patients' surgery and then afterwards for up to one year. There are no changes to participants' clinical care or surgical care as a result of the study. Investigators will also collect participants' clinical information and cancer-specific outcomes. Participants will be remunerated for their time.

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Key information

Conditions

Pediatric Cancer Childhood Bone Sarcoma Childhood Malignant Intestinal Neoplasm Childhood Malignant Liver Neoplasm Childhood Malignant Lung Neoplasm Childhood Malignant Ovarian Neoplasm Childhood Malignant Pleural Neoplasm Childhood Neuroblastic Tumor Childhood Sarcoma Childhood Soft Tissue Sarcoma Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Syndromes, Hereditary Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wilms Tumor Wilms Tumor and Other Childhood Kidney Tumors

Age range

3 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location status: Recruiting

Location contact

Stephanie F Polites, MD, MPH

CONTACT

[email protected]

507-284-2623

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3-25 years old at enrollment
  • With solid tumors of the chest, abdomen, and extremities including neuroblastic tumors, sarcoma including soft tissue and bone, kidney tumors, liver tumors, ovarian tumors, lung and pleural-based tumors, and intestinal tumors

-OR-

  • Guardian or primary caregiver of patient 3-25 years old with one of the aforementioned tumors.

Exclusion criteria

  • Patients who are known to be pregnant or prisoners.

Treatment and study plan

Wearing Smartwatch

Other

Patients and their caregivers will be asked to start wearing a smartwatch prior to surgery and continuing to wear it for one year following surgery at all times except when bathing or swimming, eating, undergoing a procedure, or if refusing to wear them. The smartwatches collect motor activity by minutes spent being sedentary, active, or highly active, heart rate, and sleep duration and stages. Data from the smartwatches syncs with Garmin connect using Fitabase to allow the study team to review the data.

Patient Report Outcomes

Other

To obtain patient-reported outcomes (PROs), questionnaires will be administered at time of enrollment, in the two weeks prior to surgery if applicable, and at 1, 2, 4, 8, 12, 16, 20, 24, 34, 44, and 54 weeks postoperatively. Questionnaires can be completed electronically, over the telephone or in person. The PedsQL Cancer Module and Patient Health Questionnaire depression scale (PHQ-9) will be utilized for questionnaires.

Blood Draw

Other

When patients are having blood drawn as part of their regular care, extra blood may be drawn for this study. Participants may opt out of this. Blood draws will occur preoperatively and at intervals postoperatively for proteomic, metabolomic, and exposomic testing.

Clinical Data Review

Other

Clinical data will be collected and stored in a database by study staff. This includes patient demographics, diagnosis characteristics including staging and risk group, treatment characteristics, and outcomes including length of stay following surgical intervention, readmissions, surgical complications including surgical site infection, time off therapy/time to resumption of chemotherapy.

Primary outcomes

  1. Surgical resilience

    Time frame: 1 year

    Using smartwatches, we will assess motor activity by minutes spent being sedentary, active, or highly active, heart rate, and sleep duration and stages. This information will be collected before and after surgical resection. Data from the smartwatches syncs with Garmin connect using Fitabase which allows the study team to monitor and analyze the data. Results will be correlated with questionnaires responses, to see if there are digital biomarker patterns associated with return to baseline quality of life postoperatively.

Secondary outcomes

  1. Quality of life - PedsQL

    Time frame: 1 year

    Results from Pediatric Quality of Life Inventory (PedsQL) Brain Tumor Module will be used to evaluate the quality of life outcomes in patients up to 18 years old. PedsQL™ assessments include 23 items answered on a Likert scale where 0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem.

  2. Quality of life - PHQ-9

    Time frame: 1 year

    The Patient Health Questionnaire (PHQ)-9 consists of 9 items related to problems over the last 2 weeks. Items are answered on a 4-point Likert scale where 0=not at all; 1=several days, 2=more than half the days; and 3=nearly every day. If any problem items were indicated, participants are asked to answer a final question with one of the following: not difficult at all; somewhat difficult; very difficult; or extremely difficult.

  3. Biomarkers

    Time frame: 1 year

    Participants who are the patients having surgery will have extra blood collected during routine clinical blood draws over time. This will be used for proteomic, metabolomic, and exposomic testing to see if specific proteins, metabolites, or chemicals are changed from baseline after surgery and if any levels are associated with improved resilience or quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Mayo Clinic Pediatric Surgery Clinical Research Unit

CONTACT

[email protected]

507-266-4467

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Digital Biomarker and Omics-Based Assessment of Surgical Resiliency in Children Undergoing Solid Tumor Resection: A Pilot Feasibility Study

Acronym: BRICCS

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Nov 5, 2024
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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